Examining the freezing process of an intermediate bulk containing an industrially relevant protein

Enzyme and Microbial Technology
Holger ReinschChristoph Herwig

Abstract

Numerous biopharmaceuticals are produced in recombinant microorganisms in the controlled environment of a bioreactor, a process known as Upstream Process. To minimize product loss due to physico-chemical and enzymatic degradation, the Upstream Process should be directly followed by product purification, known as Downstream Process. However, the Downstream Process can be technologically complex and time-consuming which is why Upstream and Downstream Process usually have to be decoupled temporally and spatially. Consequently, the product obtained after the Upstream Process, known as intermediate bulk, has to be stored. In those circumstances, a freezing procedure is often performed to prevent product loss. However, the freezing process itself is inseparably linked to physico-chemical changes of the intermediate bulk which may in turn damage the product. The present study analysed the behaviour of a Tris-buffered intermediate bulk containing a biopharmaceutically relevant protein during a bottle freezing process. Major damaging mechanisms, like the spatiotemporal redistribution of ion concentrations and pH, and their influence on product stability were investigated. Summarizing, we show the complex events which happen in an interm...Continue Reading

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Citations

May 10, 2016·International Journal of Biological Macromolecules·Kinjal A PatelIpsita Roy
May 26, 2016·International Journal of Pharmaceutics·Ľubica KrauskováDominik Heger
Nov 30, 2016·Journal of Pharmaceutical Sciences·Teddy J ZbacnikMark Cornell Manning
Apr 27, 2021·Frontiers in Bioengineering and Biotechnology·Dennis Weber, Jürgen Hubbuch
Jun 26, 2021·Biotechnology and Bioengineering·Dennis WeberJürgen Hubbuch

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